Event assessment tab—user actions

User Action Result

Click Datasheet column's icon

The system does the following:

  • Displays the license view
  • Displays the datasheet view
  • Displays the License column
  • Enables the icon for the License column

Click Product Name link

Displays the name for the selected product.

Click Event Description link

Displays the Event Information for the selected event.

Click Datasheet Description link

Displays the active on date, revision number, and first 1000 terms in the datasheet.

Click Print to view all the terms and click Export to export all the labeled terms to an Excel file in a single column with column header as Labeled Terms.

Event assessment—field descriptions

Field or Control Name Description

Recalculate

Refreshes the Event Assessment section with the newly entered data if new suspect products or events are entered, or the Event Relationship is modified.

Product

Populated when events are entered in the Products tab and appears as:

  • First Line - Product Name
  • Second Line - Generic Name

Causality as Reported/Source/ Method/ Result

Provides the source of causality as reported such as Investigator, Healthcare Professional, and so on.

Provides the method used for causality determination.

Provides the result of the causality assessment.

Causality as Determined/Source/ Method/ Result

Provides the source of causality as determined such as Sponsor, MAH, and so on.

Provides the method used for causality determination.

Provides the result of the causality assessment.

Other Causality /Source/ Method/ Result

Provides the source of causality from any additional source such as NCA.

Provides the method used for causality determination.

Provides the result of the causality assessment.

Event

Populated when events are encoded and appears as:

  • First Line - Event PT (Verbatim)
  • Second Line - LLT

D/S

Displays the Diagnosis/Symptom details by D or S.

Seriousness Severity Duration

Displays the seriousness, severity, and the duration of the event.

Listedness

Indicates whether the system found the event on the datasheet for this product.

This field is enabled for company products and non-company study drugs.